Actively Recruiting
An Open-Label, Dose Escalation, Multi-Center Phase I/II Clinical Trial of EB103 T-Cell Therapy in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
Led by Estrella Biopharma, Inc. · Updated on 2025-08-07
21
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
E
Estrella Biopharma, Inc.
Lead Sponsor
E
Eureka Therapeutics Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating an autologous T-cell therapy called EB103 in adults aged 18 years and older with relapsed or refractory B-cell Non-Hodgkin's lymphoma (NHL). This open-label Phase I/II trial aims to assess the safety of EB103 and determine the Recommended Phase II Dose (RP2D), including a dose escalation phase followed by an expansion phase. The study is designed to better understand how EB103 may work in this patient population. The trial uses a traditional 3+3 dose escalation model where approximately six participants will receive escalating doses to find the RP2D. After establishing the RP2D, about fifteen more subjects will be treated at this dose during the expansion phase to confirm safety and evaluate preliminary effectiveness. EB103 involves using a participant's own T cells, which are modified with a lentiviral vector to express the EB103 transgene. Participants will undergo assessments to monitor dose-limiting toxicities within 28 days, treatment-emergent adverse events, and laboratory abnormalities over 90 days. The study will also assess response rates, disease control, duration of response, progression-free and event-free survival, overall survival, and pharmacokinetic profiles of EB103 for up to two years. Researchers will carefully monitor safety and collect data throughout the study, which is expected to continue until December 2027.
CONDITIONS
Brief Title
T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of informed consent
- Histologically confirmed relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL)
- Adequate organ function
- Relapsed or refractory disease defined as one or more of the following:
- Relapsed or refractory after two or more lines of systemic therapy
- For Burkitt lymphoma, precursor B-cell lymphoblastic lymphoma, or mantle cell lymphoma: relapsed or refractory after one or more lines of systemic therapy
- Disease progression or recurrence within 12 months after autologous hematopoietic stem cell transplantation (HSCT)
- For transplant-ineligible subjects: progressive disease after four or more cycles of first-line therapy and stable disease after two or more cycles of second-line therapy; prior treatment must include an anti-CD20 monoclonal antibody and an anthracycline
- All subjects must have received chemoimmunotherapy including an anti-CD20 monoclonal antibody and an anthracycline-containing chemotherapy regimen
- Positron emission tomography (PET)-positive disease according to Cheson 2014
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Toxicities from prior therapy must be stable and recovered to Grade 1 or less
You will not qualify if you...
- Prior CD19-targeted cellular therapy
- History of Richter's transformation of chronic lymphocytic leukemia (CLL)
- History of another primary malignancy not in remission for at least 2 years
- History or presence of clinically relevant central nervous system (CNS) pathology
- CNS disease progressing on most recent therapy or with symptomatic parenchymal mass
- Active cardiac lymphoma involvement not responding to treatment
- History of recent (within 6 months) myocardial infarction, cardiac angioplasty and stenting, unstable angina, or other significant cardiac disease
- Active, uncontrolled systemic bacterial, fungal, or viral infection
- History of autoimmune disease causing organ injury or requiring systemic immunosuppression within last 2 years
- History of severe, immediate hypersensitivity reaction to study agents including conditioning chemotherapy
- Venous thrombosis or embolism not stabilized by anticoagulation
- Autologous HSCT within 3 months prior to informed consent
- Prior allogeneic transplant at least 6 months prior unless no ongoing graft-versus-host disease requiring systemic treatment within 12 weeks
- Live vaccine within 3 months prior to planned start of conditioning regimen
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 21 months
Participants receive EB103, an autologous T-cell therapy, to treat relapsed or refractory B-cell Non-Hodgkin's Lymphoma. The dose is escalated to determine the recommended phase II dose, followed by treatment at this dose.
Visits scheduled according to dose escalation and expansion phase requirements
Duration - Up to 2 years
Participants are monitored for safety and treatment response after receiving EB103, including assessments of adverse events and disease status.
Regular visits for monitoring and assessments
Trial Site Locations
Total: 2 locations
1
University of California, Davis
Sacramento, California, United States, 95817
Actively Recruiting
2
Baylor Scott & White Research Institute, Texas Oncology
Dallas, Texas, United States, 75246
Actively Recruiting
Research Team
T
Teresa Klask, MBA
P
Pei Wang, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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